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ABBOTT's PROSOM BENZODIAZEPINE SEDATIVE/HYPNOTIC APPROVED FOR SHORT-TERM MANAGEMENT OF INSOMNIA; MARKET LAUNCH WILL BEGIN "WITHIN THE NEXT FEW WEEKS"

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Executive Summary

Abbott Labs plans to launch the sedative/hypnotic ProSom (estazolam) "within the next few weeks" following FDA approval on Dec. 26. ProSom, a benzodiazepine hypnotic, will compete with Upjohn's Halcion. FDA awarded the drug a "1C" rating, denoting a new molecular entity representing little or no therapeutic gain over other available marketed drugs. ProSom 1 mg tablets will be priced to wholesalers at $ 45.43 for 100s, which is slightly higher than Upjohn's direct price to wholesalers of $ 43.39 for 100 Halcion .25 mg tablets. ProSom is indicated for "the short term treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings." The approved labeling notes that "there is evidence to support the ability of ProSom to enhance the duration and quality of sleep for intervals of up to 12 weeks." The ProSom approval will add a new product to Abbott's older stable of CNS agents. ProSom will be Abbott's second drug in the hypnotic market after Placidyl (ethchlorvynol). The new sedative/hypnotic also will be the company's second benzodiazepine product to reach the U.S. market after the anxiolytic Tranxene (clorazepate). The NDA for ProSom was first filed with FDA in December 1983 under Abbott's joint venture agreement in the U.S. with Takeda. Abbott later assumed the U.S. rights to market ProSom from Takeda- Abbott Pharmaceuticals (TAP) in 1988. Concerns about the benzodiazepine product's safety initially delayed its approval in this country and were not put to rest until Abbott conducted a long-term safety study that compared ProSom to Halcion in approximately 350 patients with various sleeping disorders. The results of that study were submitted to FDA in December 1988. ProSom has been marketed outside of the U.S. for over eight years and is currently sold in Japan, Portugal, Brazil and France, Abbott said. ProSom will be available in 1 mg and 2 mg tablet forms. The drug's labeling recommends an initial dose for adults of "1 mg at bedtime," but adds that "some patients may need a 2 mg dose." The labeling also suggests that a starting dose of .5 mg "should be considered" for "small or debilitated older patients." Like Halcion, the clinical pharmacology section of the ProSom package insert contains a general warning statement on the "postulated relationship between the elimination rate of benzodiazepine hypnotics and their profile of untoward effects." These untoward effects, according to labeling, include "impairments of cognitive and/or motor performance during the waking hours;" "incidence of increased wakefulness during the last third of the night;" and "the appearance of increased daytime anxiety" among patients receiving rapidly eliminated benzodiazepines for periods of several weeks. The warning section of ProSom's package insert also cautions physicians about possible neurological side effects of drugs in this class, most notably episodes of amnesia and central nervous system depression. In addition, the labeling notes that "there have been reports of withdrawal signs and symptoms of the type associated with withdrawal from CNS depressant drugs following the rapid decrease or the abrupt discontinuation of benzodiazepines." Both ProSom and Halcion are Schedule IV controlled substances. The sedative/hypnotic is Abbott's third new drug approval in the last four years after cardiovascular product approvals for Hytrin (terazosin) in August 1987 and Cartrol (carteolol) in December 1988. During the same time period, Abbott's joint venture with Takeda, TAP, generated two cephalosporin antibiotic approvals: Cefmax (cefmenoxime) in 1987 and Ceradon (cefotiam) in 1988. However, neither product has been introduced in the U.S.